1. Male or female patients of 18 years or older.
2. Patient must have a diagnosis of a CD30+ Hodgkin Lymphoma or CD30+ peripheral T-cell
lymphoma. Patients with either Hodgkin lymphoma or T-cell lymphoma must have
expression of CD30 in ≥10% of lymphoma cells. Patients with CTCL will be considered
for inclusion even if CD30 immunohistochemical staining with BerH2 antibody is low or
1. Peripheral T-cell lymphoma: patients must be considered relapsed or refractory
after at least one prior chemotherapeutic regimen or be considered by the
investigator to be not suitable for chemotherapy
2. Cutaneous T-cell lymphoma: patients must be relapsed or refractory to one prior
systemic therapy or be considered by the investigator to be not suitable for
3. Patients with Hodgkin lymphoma and one of the following:
i. Relapsed or refractory after at least 2 prior chemotherapy-containing regimens
ii.Considered unsuitable for chemotherapy
3. Voluntary written informed consent must be given before performance of any study-
4. Female patient is either post-menopausal for at least 1 year before the screening
visit or surgically sterile or if of childbearing potential, agree to practice 2
effective methods of contraception, at the same time, from the time of signing the
informed consent through 6 months after the last dose of study drug, or agrees to
completely abstain from heterosexual intercourse.
5. Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to
practice effective barrier contraception during the entire study period and through 6
months after the last dose of study drug, or agrees to completely abstain from
6. Performance status of ECOG ≤2.
7. Clinical laboratory values as specified below. Blood tests must be within 10 days of
- Absolute neutrophil count >1.5 x109/L, or >1.0 x109/L in the setting of known
marrow involvement by tumour.
- Platelet count ≥75x109/L.
- Total bilirubin must be < 1.5 x the upper limit of the normal (ULN) unless the
elevation is known to be due to Gilbert syndrome.
- ALT or AST must be < 2.5 x the upper limit of the normal range. AST or ALT may be
elevated up to 5 times the ULN if their elevation can be reasonably ascribed to
the presence of haematologic/solid tumor in liver.
- Serum creatinine must be < 150 µmol/L and/or creatinine clearance or calculated
creatinine clearance > 40 mL/minute.
- Haemoglobin must be ≥ 80g/L.
8. Patients must have fully recovered from the acute toxic effects of all prior
chemotherapy, immunotherapy, or radiotherapy (except alopecia) prior to registration.
1. Female patients who are both lactating and breast-feeding or have a positive serum
pregnancy test during the screening period or a positive pregnancy test on planned
cycle 1, day 1 prior to first dose of study drug.
2. Any serious medical or psychiatric illness that could, in the investigator's opinion,
potentially interfere with the completion of treatment according to the protocol.
3. Symptomatic neurologic disease compromising normal activities of daily living or
requiring medication/s, including signs or symptoms of Progressive Multifocal
4. Any sensory or motor peripheral neuropathy greater than or equal to Grade 2 at
5. Known history of any of the following cardiovascular conditions
1. New York Heart Association (NYHA) Class III or IV heart failure (see Appendix
2. Evidence of current uncontrolled cardiovascular conditions, including cardiac
arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic
evidence of acute ischemia or active conduction system abnormalities.
3. A left-ventricular ejection fraction <50%
6. Any active systemic viral, bacterial, or fungal infection requiring systemic
intravenous antibiotics or systemic antifungal therapies within 2 weeks prior to
7. Patients that have not completed any prior treatment chemotherapy and/or other
investigational agents within at least 5 half-lives of last dose of that prior
8. Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient
contained in the drug formulation of brentuximab vedotin or lenalidomide.
9. Known human immunodeficiency virus (HIV) positive.
10. Known hepatitis B surface antigen (HBsAg)-positive, or known or suspected active
hepatitis C infection. Patients who are Hepatitis B core antibody positive with no
evidence of active disease, i.e.
HBsAg negative/ negative hepatitis B viral load, will still be considered eligible for
inclusion, but must receive viral suppressive therapy for the duration of the trial.
11. Active systemic malignancy likely to require treatment within the next two years, or
previous diagnosis of another malignancy with residual disease. Patients with
non-melanoma skin cancer or carcinoma- in-situ of any type are not excluded if they
have undergone complete resection.
12. Previous exposure to brentuximab vedotin.